The following data is part of a premarket notification filed by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. with the FDA for Surgical Masks.
| Device ID | K212807 |
| 510k Number | K212807 |
| Device Name: | Surgical Masks |
| Classification | Mask, Surgical |
| Applicant | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. No. 567 Gushan Road, Area Of Economy And Technique Weihai, CN 264205 |
| Contact | Bin Dong |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd Rm. 912, Building #15, XiYueHui, No.5, YiHe North RD., FangShan District Beijing, CN 102401 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-03 |
| Decision Date | 2021-12-03 |